Vice President of Regulatory Affairs

About the role

A patient-focused biotechnology organization is hiring a senior regulatory executive to provide enterprise leadership across Regulatory Affairs, Clinical Operations, and Medical Affairs.

Key Responsibilities

• Set global regulatory strategy for commercial products, clinical programs, manufacturing changes, and future pipeline initiatives
• Lead IND, BLA, amendment, supplement, and post-approval submission activities
• Represent the organization in FDA meetings, health authority interactions, inspections, and regulatory responses
• Oversee clinical trial execution, CROs, vendors, budgets, timelines, enrollment, and operational risk
• Guide Medical Affairs strategy, scientific publications, advisory boards, KOL relationships, and medical education
• Support investigator-sponsored studies, real-world evidence, and post-marketing clinical programs
• Ensure compliance with FDA requirements, GCP, ICH, GMP, and applicable global regulations
• Advise executive leadership on regulatory, clinical, and medical risks and opportunities
• Establish departmental objectives, budgets, KPIs, and long-term organizational plans
• Recruit, develop, and lead high-performing regulatory and clinical teams

Required Background

• MS, PharmD, PhD, MD, or equivalent advanced scientific degree
• 15+ years in biotechnology, pharmaceuticals, or biopharmaceuticals
• 10+ years of Regulatory Affairs leadership
• Successful IND and BLA submission leadership
• Direct FDA and health authority meeting experience
• Significant Clinical Operations and clinical trial oversight experience
• Medical Affairs, scientific communications, and KOL engagement experience
• Product development, approval, commercialization, and lifecycle management experience
• Oncology, immunotherapy, cell therapy, cellular therapy, or biologics experience preferred
• Experience managing multidisciplinary teams, CROs, vendors, and consultants
• Willingness to work onsite in Seal Beach, California
• Availability for up to 30% domestic and international travel

Opportunity Highlights

• Commercial-stage biotechnology organization
• Established FDA-approved cellular immunotherapy platform
• Executive ownership across Regulatory Affairs, Clinical Operations, and Medical Affairs
• Direct interaction with senior leadership and board members
• Meaningful influence over commercial and pipeline strategy
• Executive bonus opportunity and relocation assistance